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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problems Pain (1994); Sleep Dysfunction (2517)
Event Date 12/27/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient regarding their implantable neurostimulator (ins). Information was reported that the patient said since (b)(6) 2019 when she bares weight she feels pain where the ins is and it travels across her butt, hip, and down to her knee on her left side. The patient said that she had x-rays of her hip and knee and said that nothing is wrong. The patient is wondering if the ins could have shifted and is on a nerve. The patient mentioned that her insis for her si joint on her right side. It was recommended that the patient follow up with her healthcare provider (hcp). Additional information was received from the patient. It was reported that the hcp thought that the hcp thought the cause of the pain was the si joints. The patient said they had bilateral si joint injections ordered, dye #3, and prn for pain were done to resolve the issue. The pain was not yet resolved. Additional information was received from the patient. The patient wanted to address the questions. Patient reported she does not know if the pain was caused by the implant or not. Patient stated that she has been dealing with the pain and she stated her doctor informed her that the implant is not what was causing her the pain. Patient stated they were going to have to get two si injections and was hopefully getting an mri at least of her knee. Patient stated the pain has not resolved. Patient stated that she was in so much pain that she could not sleep at night and the pain went up and down. Patient to call back when she figures out the questions and will keep manufacturer informed. Pt reported that she has not noticed much difference from having the stimulator turned off for a few weeks and then having it turned on. Pt stated that she will be having blocks as well as an ablation and more tests. Pt said her pain dr. Told her that the stimulator will not help with the si joint problem. Pt mentioned that with the location of the battery, she can feel the corners and it feels like the battery could just come through the skin because it's so close to the top on the buttocks, and the neurosurgeon asked why they put it so low.
 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11147838
MDR Text Key226065496
Report Number3004209178-2021-00508
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Model Number97715
Device Catalogue Number97715
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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